Cobas is an early example of personalized medicine" morphing from futurist claptrap into something tangible--and a harbinger of how the worlds of devices and diagnostics are converging on those of pharmas and biotechs.

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"Molecular diagnostics is leading the way to personalized healthcare," says Whitney Green, senior vice president, commercial operations for molecular diagnostics at Roche. "The past approach was more of a shotgun approach. If someone's sick, you give them a certain therapy, and if it works, great. And, if it doesn't, you go on to the next one. which isn't the best way to deliver healthcare. As we use molecular diagnostics, we're better able to diagnose and predict therapy or outcomes that essentially, over time, will make the healthcare system more efficient"

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The Roche test is the third-to-markel in its class, and like its competitors--Qiagen's Digene test and Hologic's Cervista assays--it will be marketed for use, in conjunction with a Pap smear, in identifying women who are at high risk of cervical cancer (some form of HPV is present in XX% of cervical cancer cases).

Roche's differentiating point is that it offers concurrent i testing for a "pool" of common genotypes and for the two deadliest forms.

"Having it 'all in one' provides much more timely information for the patient, so that they don't have to wait around and possibly come in for another sample," says Roche's Green "and you get a very accurate, clinically relevant result with that sample integrity." Patients who test positive for HPV types XX or XX get a colposcopy to look for cancerous lesions.

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Roche's massive ATHENA study for the test, which involved more than XX,XXX US women, found that one in XX women XX and over who tested positive for XX and/or XX had cervical pre-cancer even though the Pap test showed no sign of trouble. Cervical cancer kills X.XXX women a year in the US. and there are XX,XXX new cases per year here. The disease is highly treatable if caught early.

Upward of XX million Pap smears are performed every year in the US, compared to around XX-XX million high-risk HPV tests.

Co-testing is becoming the standard for women over XX, but there remains much room for growth--especially considering relatively low rates of HPV vaccination, and that virtually all women over XX have never been vaccinated.

Selling the razor blade

Pap smears reduced deaths from cervical and uterine cancers by XX% between XXXX and 2004, according to the American Cancer Society, but the ATHENA study raises the question: Could high-risk HPV testing ever become the primary form of testing?

"That's the $XX million dollar question," says Green.

For the time being, the Roche test needs to grab some share from two entrenched competitors. Qiagen, which bought market pioneer Digene, is far and away the category leader. Its Digene test, approved in 2003, was the first of its kind.

"We'd been working for years with the medical guidelines and evidence to support the standard of care, and I think you're seeing that the science has proven itself so much that competitors are coming to market," says Qiagen's Shelly Ducker, associate director of communications. "So, we feel pretty good about the market we've created, but we also still feel good about our product as well."

The Digene test, says Ducker, has the weight of XXX clinical trials and more than a million patients behind it--and no product, she contends, has demonstrated clinical superiority, all these years later.

That said, the validity of the test itself is only half the battle, because while the test companies market their products to physicians--and sometimes to consumers--they must also sell the machines that run the tests to labs, and for those customers, ease of use is of paramount importance. "Labs want a lot of automation," says Ducker. "They want an instrument that's quick and that they can run a menu on, so that they can do HPV on Monday and Tuesday and chlamydia and gonorrhea on Thursday and Friday."

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And doctors typically don't have a say in what HPV test they re running--they just check a box and order a test from the lab.

"Labs are a complicated audience with a lot of sub-industries," notes Ducker. For HPV, the big customers are hospital-based molecular labs and so-called research labs--Quest Diagnostics, LabCorp, etc. The broader market might include epidemic research, drug company clinical trials, food safety and veterinary testing.

Roche declined to specify a ballpark sticker price for its Cobas XXXX machine, for which a gonorrhea and chlamydia test is in development, too. Prices vary widely based on the purchaser and expected volume of tests but it's somewhere in the six-figure range ("under a million," says Green), and the cost to patients is around $XX-$XX. But the company is looking to profit on the volume of tests, not on sales of the instrument.

'To be honest, we're not that interested in selling the razor,X' says Green. "We're much more interested in selling the razor blade. If it's running XX,XXX HPV tests per year, the cost of the instrument becomes irrelevant."'

One Less is more

Qiagen, Hologic and Roche have been aided greatly in their marketing efforts by those of Merck and GlaxoSmithKline on behalf of their HPV vaccines, Gardasil and Cervarix respectively. Together, the companies have, over the past six years, raised HPV awareness to near-universal levels, and though their products are indicated for teenagers, they're pitched to their moms, who are the target market for the tests.

"We used to say ignorance is our biggest competitor, but the times are changing," says Qiagen's Ducker. "There was a period where you couldn't turn on the TV without seeing the Merck [One Less] ad. The challenge we have now is that they hear 'HPV' and because there's so much investment and awareness, they're asking for the vaccine. Women are researching HPV for their daughters, and the challenge is to flip that awareness and say, "OK, moms, here's something you can do for yourself.'"